How E-connected medicine will change the value of pharmaceuticals. Overview of current initiatives on digital pill

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1 How E-connected medicine will change the value of pharmaceuticals Overview of current initiatives on digital pill Professor Mondher Toumi Aix Marseille University ISPOR Asia Pacific 08 Agenda Burden of non compliance Overview of the potential advantages of current digital pills initiative from various perspectives Patient Caregiver Doctor Provider Effectiveness and efficiency and consideration in HTA evaluation

2 Burden of non compliance Recent study estimated that the annual adjusted disease-specific economic cost of non-adherence per person ranged from $949 to $44 90 (in 05 US$) Rachelle Louise Cutler et al. BMJ Open 08;8:e0698 Simple initiative often not sufficient A very large randomized clinical trial ( enrollees of a pharmacy benefit manager) did not show a statistically significant difference in adherence was found between those in the control group and those who received a reminder device (pill bottle strip with toggles, digital timer cap, or standard pillbox) JChoudhry NK. Effect of Reminder Devices on Medication Adherence: The REMIND Randomized Clinical Trial. JAMA Intern Med. 07 May ;77(5):64-63.

3 Current initiatives Severe Mental Illness In 07 U.S. regulators approved the first medicine with an embedded sensor to help keep track of whether patients with mental illness are adhering to their prescriptions. Hepatitis C,3 Denver Health is conducting study using digital pill to track adherence and compliance of Hepatitis, a viral disease that impacts the liver and can be fatal but is also curable through often expensive medicines. Opioids 3 Denver Health is conducting study using digital pill to track adherence and compliance Chai et al. Med Internet Res. 07 Jan 3;9()Digital Pills to Measure Opioid Ingestion Patterns in Emergency Department Patients With Acute Fracture Pain: A Pilot Study. Severe Mental Illness Principle of Digital medicine system (DMS) Neuropsychiatric Disease and Treatment 08:

4 Benefits (/) The pill will allow doctors to track better than ever how well people stick to a course of medication. Understand the reason for poor efficacy Will support the caregiver in helping patient monitoring treatment intake and decrease anxiety of caregiver on patient s compliance Dialogue on adherence and reassurance May also discover vital new information about treating hepatitis C or SMIR and respond to the question on how often you need to take your hepatitis C or SMI medication to be cured Infor; development strategy and new vision of adherence Benefits (/) For opioid determining adherence to a prescribed medication regimen and measuring the ways in which patients ingest asneeded medications pose methodological challenges with usual methods patients determine opioid ingestion dose and frequency based on temporal perception of pain thus common measures of adherence (eg, smart pill bottles, pharmacy refill histories, or patient diaries) are impractical or provide aggregate measures that cannot delineate temporal patterns of opioid ingestion. Precise measures of opioid ingestion patterns are important because they can suggest incomplete treatment of pain, the development of tolerance, or the transition into problematic use Chai et al. Med Internet Res. 07 Jan 3;9()Digital Pills to Measure Opioid Ingestion Patterns in Emergency Department Patients With Acute Fracture Pain: A Pilot Study. DN, Dhalla IA. Dependence and addiction during chronic opioid therapy. J Med Toxicol. 0 Dec;8(4):

5 Concern DMS can be seen as a form of surveillance and may be experienced as intrusive, coercive, or an invasion of privacy by people who experience mental illness There are legitimate reasons people may be mindfully nonadherent to prescribed medication regimens, such as psychological resistance to treatment, wishes to avoid undesirable side effects burdensome medication costs, a lack of trust in providers advice, and treatment goals that may conflict with those of their providers including attempts to decrease medication use. Behavioral psychology acceptability Absent strict legal orders, people have the right to manage their medications without oversight or covert pressure. Dotolo D et al. A Hard Pill to Swallow: Ethical Problems of Digital Medication. Soc Work. 08 Aug. Discussion Digital pill is a promising new tool that Should be mandatory in clinical trials could benefit patients, caregiver and doctors Open a new field of the most important clinical pharmacology topic Enhance value for payer and society Will allow researchers to understand better the use of medications in a unprecedented way that could influence the development of new drugs However ethical concerns must be consider so this tool does not become a coercive tool 5